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FDA 510(k), K141220, APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
FDA 510(k), K141220, APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
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510(K) Number: K141220
Device Name: APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
Manufacturer: THERMO FISHER SCIENTIFIC (LIFE TECHNOLOGIES HOLDIN
Device Classification Name: instrumentation for clinical multiplex test systems
Regulation Number: 862.2570
Classification Product Code: NSU
Date Received: 05/12/2014
Decision Date: 05/22/2014
Regulation Medical Specialty: Clinical Chemistry
Device Name: APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
Manufacturer: THERMO FISHER SCIENTIFIC (LIFE TECHNOLOGIES HOLDIN
Device Classification Name: instrumentation for clinical multiplex test systems
Regulation Number: 862.2570
Classification Product Code: NSU
Date Received: 05/12/2014
Decision Date: 05/22/2014
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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